Omission of Controlled Cord Traction During Active Management of Third Stage of Labor

Omission of Controlled Cord Traction During Active Management of Third Stage of Labor. A Single Blinded Randomized Controlled Trial

This is a comparative study which will be conducted in Ain Shams University Maternity hospital to assess the individual and specfic role of controlled cord traction as a part of active management of third stage of labor

Study Overview

• Status: Unknown
• Conditions: Labor Stage, Third
• Intervention / Treatment: Procedure: Ommited controlled cord traction; Procedure: controlled cord traction

Detailed Description

300 patients will be randomized into two groups with controlled cord traction and withoout. The primary outcome will be sever postpartum haemorrhage

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Qahirah
    • Cairo, Al Qahirah, Egypt
      • Recruiting
      • Faculty of Medicine, Ain Shams University
      • Contact: ahmed kotb, MD; Phone Number: 2001008681999; Email: ahmedmkotp@hotmail.com
      • Contact: ahmed kotb; Email: ahmedmkotp@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• singleton pregnancy
• term pregnancy

Exclusion Criteria:

• episiotomy
• operative vaginal delivery
• known coagulation defect
• Acute complication during labor e.g. eclampsia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: omiited controlled cord traction; neither controlled cord traction nor fundal pressure will be applied. The placenta will be delivered physiologically and signs of placental separation will be awaited	Procedure: Ommited controlled cord traction; No controlled cord traction and no fundal pressure. placenta will be allowed to deliver physiologically
Active Comparator: controlled cord traction; the cord will be held in one hand and the other hand will be placed just above the woman's pubic boneto stabilize the uterus during cord traction	Procedure: controlled cord traction; active management of third stage of labor in the form of uterine massage with controlled cord traction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sever post partum haemorrhage	blood loss more than 500 cc	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of third stage of labor	from delivery of the baby to delivery of the placenta	30 minutes

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Ahmed M kotb, MD, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 14, 2016

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 14, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No